Quality Assurance Manager
JOB DESCRIPTION: Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals. Abbott serves people in more than 150+ countries and employs approximately 97,000 people. In Ireland, Abbott has five business units, represented across eight manufacturing sites. The Abbott Diabetes Care division based in Donegal Town manufactures FreeStyle blood glucose test strips for use in diabetes management. Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre system. The main responsibility of the Quality Assurance Manager is to manage a team of Quality Team Leads/Engineers/Processors, ensuring the site delivers safe and effective products that meet customer needs whilst maintaining compliance. Responsibility for implementing Quality objectives and ensuring short term and long-term quality goals are achieved. Responsibilities: Development and implementation of company wide quality systems and policy compliance to FDA QSRs, ISO13485, MDR and IVDD. Manage the quality department staff, their training and development. Manage the non-conformance(CAPA), Documentation Control, Suppliers and Product Release processes. Analyse product quality and process data using statistical techniques to identify trends and implement improvement plans accordingly. Support the Engineering Change Control process, ensuring compliance with internal compliance and applicable quality and regulatory requirements. Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by Management. Experience Required: A relevant third level qualification in Engineering/Manufacturing/Science. Minimum Training/Experience Required: 5 years relevant experience in a similar environment preferred. Supervisory experience required. This job originally appeared on RecruitIreland.com.
259 days ago